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510(k) K060167

ATRIA 3100, ATRIA 6100 by Cardiac Science Corporation — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2006
Date Received
January 23, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

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  • K093211 — CARECENTER MD (June 3, 2010)
  • K091943 — POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A (September 10, 2009)
  • K082090 — 9131 DEFIBRILLATION ELECTRODES (December 12, 2008)
  • K082173 — Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S (August 26, 2008)
  • K060934 — MODIFICATION TO POWERHEART ECD (May 15, 2006)

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